Now Hiring: Quality Systems Engineer Location : On-site in Irvine, CA | Schedule: Mon–Wed + Every Other Friday About the Role Are you ready to lead the charge in building a new Quality Management System (QMS) from the ground up? As a Quality Systems Engineer, you’ll play a pivotal role in shaping the future of our Neurovascular division. This is a high-impact opportunity to drive compliance, innovation, and operational excellence as we prepare for a major site qualification audit in early 2026. You’ll collaborate across departments to ensure our systems meet and exceed global regulatory standards—including ISO 13485:2016, FDA QSR/QMSR, and EU MDR—while supporting continuous improvement and certification readiness. What You’ll Do + Lead the execution of quality plans and QMS implementation for a new site. + Partner with cross-functional teams to drive certification and compliance strategies. + Ensure audit readiness and provide expert support during regulatory inspections. + Support continuous improvement initiatives and system integration efforts. + Update Quality Manuals and Systems in alignment with evolving regulations. + Collaborate with R&D, Regulatory Affairs, Supply Chain, Marketing, and more. What You Bring + 6+ years of experience in Quality Engineering, preferably in medical devices. + Proven success leading QMS build-outs and quality planning. + Expertise in FDA, ISO, and EU MDR regulations. + Proficiency with Windchill and ETQ systems. + Strong understanding of compliance, quality assurance, and regulatory affairs. + Bonus: Experience in neurovascular or high-risk medical device environments. Why Join Us? This is more than a job—it’s a chance to build something meaningful. You’ll be joining a team at a critical moment of transformation, with the autonomy to shape systems that ensure patient safety and product excellence. If you're passionate about quality, compliance, and making a difference in healthcare, we want to hear from you. Pay and Benefits The pay range for this position is $60.00 - $75.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Irvine,CA. Application Deadline This position is anticipated to close on Jul 29, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.